Bringing Advanced Therapy Medicinal Products Atmps To The Clinic And Beyond How To Ensure The Sustainable And Affordable Introduction Of Atmps Into Healthcare
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Bringing Advanced Therapy Medicinal Products Atmps To The Clinic And Beyond How To Ensure The Sustainable And Affordable Introduction Of Atmps Into Healthcare
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Author : Hans-Dieter Volk
language : en
Publisher: Frontiers Media SA
Release Date : 2022-11-30
Bringing Advanced Therapy Medicinal Products Atmps To The Clinic And Beyond How To Ensure The Sustainable And Affordable Introduction Of Atmps Into Healthcare written by Hans-Dieter Volk and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-11-30 with Medical categories.
Regulatory Aspects Of Gene Therapy And Cell Therapy Products
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Author : Maria Cristina Galli
language : en
Publisher: Springer
Release Date : 2015-09-15
Regulatory Aspects Of Gene Therapy And Cell Therapy Products written by Maria Cristina Galli and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-09-15 with Medical categories.
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Establishing A Hematopoietic Stem Cell Transplantation Unit
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Author : Éliane Gluckman
language : en
Publisher: Springer
Release Date : 2017-11-17
Establishing A Hematopoietic Stem Cell Transplantation Unit written by Éliane Gluckman and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-17 with Medical categories.
This text aims to provide simplified practical guidelines to start a hematopoietic stem cell transplantation unit which could be implemented in most centers and countries worldwide. The book also provides guidelines for existing transplantation units to upgrade their practice and implement new policies and procedures, in addition to developing therapies according to latest international standards and regulations. The book covers a wide range of practical implementation tools including HSCT program team structure, building inpatient and outpatient HSCT units, requisite laboratory support for transplantation program, practical aspects of stem cell collection and processing, HSCT program quality management, education and training, and data management. The book also addresses cost effectiveness and recommendations for establishing transplantation program in countries with limited resources. Written by group of internationally established experts in their corresponding hematopoietic stem cell transplantation fields, with contributions from many leaders of hematopoietic stem cell transplantation organizations, Establishing a Hematopoietic Stem Cell Transplantation Unit: A Practical Guide is an essential, practical resource for all members of the multidisciplinary hematopoietic stem cell transplantation team.
The Ebmt Handbook
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Author : Enric Carreras
language : en
Publisher: Springer
Release Date : 2019-01-03
The Ebmt Handbook written by Enric Carreras and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-01-03 with Medical categories.
This Open Access edition of the European Society for Blood and Marrow Transplantation (EBMT) handbook addresses the latest developments and innovations in hematopoietic stem cell transplantation and cellular therapy. Consisting of 93 chapters, it has been written by 175 leading experts in the field. Discussing all types of stem cell and bone marrow transplantation, including haplo-identical stem cell and cord blood transplantation, it also covers the indications for transplantation, the management of early and late complications as well as the new and rapidly evolving field of cellular therapies. This book provides an unparalleled description of current practices to enhance readers’ knowledge and practice skills.
Methods For The Economic Evaluation Of Health Care Programmes
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Author : M. F. Drummond
language : en
Publisher: Oxford [Oxfordshire] ; Toronto : Oxford University Press
Release Date : 1987-01
Methods For The Economic Evaluation Of Health Care Programmes written by M. F. Drummond and has been published by Oxford [Oxfordshire] ; Toronto : Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1987-01 with Medical categories.
As concern over costs grows in the health care sector, those involved in health economics require a clear understanding of methods used in cost-effectiveness, cost benefit, and cost-utility studies. This book provides the reader with the necessary methodological tools for undertaking the task of economic evaluation and includes discussions of many case studies, helpful illustrations, and simple exercises.
Qualitative Research Methods
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Author : Monique Hennink
language : en
Publisher: SAGE
Release Date : 2010-11-30
Qualitative Research Methods written by Monique Hennink and has been published by SAGE this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-11-30 with Social Science categories.
Lecturers, click here to request an e-inspection copy of this text Qualitative Research Methods is based on the authors′ highly successful multidisciplinary qualitative methods workshops, which have been conducted for over a decade. In this book the authors propose a ′qualitative research cycle′ that leads students through the selection of appropriate methods, the collection of data and the transformation of findings into a finished project. It provides a clear explanation of the nature of qualitative research and its key concepts. Topics covered include: o formulating qualitative research questions o ethical issues o in-depth interviews o focus group discussions o observation o coding o data analysis o writing up qualitative research This text is ideal for any students taking a qualitative methods course or producing a qualitative research project at undergraduate or graduate level. It is illustrated throughout with case studies and field examples from a range of international contexts. The practical techniques are also accompanied by the author′s own research tools including interview guides, real coded data and comprehensive research checklists.
Guidelines For The Blood Transfusion Services In The United Kingdom
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Author : United Kingdom Blood Transfusion Services
language : en
Publisher: Stationery Office
Release Date : 2005-10-12
Guidelines For The Blood Transfusion Services In The United Kingdom written by United Kingdom Blood Transfusion Services and has been published by Stationery Office this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-10-12 with Medical categories.
This is the seventh edition of a book that provides best practice guidelines and detailed technical procedures for blood transfusion services. It takes account of the European Directives on blood and tissues and resulting UK regulations and indicates which of the guidelines that are now legal requirements.
Advanced Non Animal Models In Biomedical Research
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Author :
language : en
Publisher:
Release Date : 2022
Advanced Non Animal Models In Biomedical Research written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022 with categories.
Advanced therapy medicinal products (ATMPs) are a fast-growing class of innovative biological products. They include somatic cell therapy, gene therapy, tissue-engineering and their combinations, and they hold the key for new treatments for rare diseases and the establishment of personalised medicine. Nevertheless, several hurdles are currently hampering the faster development and wider clinical use of ATMPs, one of which is safety and their immunogenic potential. Testing for immunogenicity of cell-based, gene-based or tissue-engineered products in animals has uncovered the intricate limitations of in vivo models. There is, therefore, a growing need for innovative non-animal methods to better mimic patient immune responses to ATMPs. The JRC's EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) conducted a study to review the state-of-the art of advanced non-animal models used in immunogenicity testing for ATMPs. The majority of the 88 models that were identified were based on in vitro techniques with a limited amount of in silico methods, and most of these focused on the investigation of cell therapy products. Furthermore, most of the identified methods used classical 2D primary cell cultures in a low throughput format, typically yielding limited amounts of measurement information. This review highlights a pressing need for the development and acceptance of more sophisticated and innovative non-animal approaches in this field which will pave the way for the broader use of ATMPs in the clinic.
Clinical Translation And Commercialisation Of Advanced Therapy Medicinal Products
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Author : Tracy Tong Li Yu
language : en
Publisher: Frontiers Media SA
Release Date : 2021-01-21
Clinical Translation And Commercialisation Of Advanced Therapy Medicinal Products written by Tracy Tong Li Yu and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-21 with Science categories.
Dr. Yves Bayon is a Senior Principal Scientist at Medtronic and Dr. Alain Vertes is affiliated with NxR Biotechnologies GmbH. All other Topic Editors declare no competing interests with regards to the Research Topic subject.
Advanced Non Animal Models In Biomedical Research
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Author :
language : en
Publisher:
Release Date : 2022
Advanced Non Animal Models In Biomedical Research written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022 with categories.
Advanced therapy medicinal products (ATMPs) are a fast-growing class of innovative biological products. They include somatic cell therapy, gene therapy, tissue-engineering and their combinations, and they hold the key for new treatments for rare diseases and the establishment of personalised medicine. Nevertheless, several hurdles are currently hampering the faster development and wider clinical use of ATMPs, one of which is safety and their immunogenic potential. Testing for immunogenicity of cell-based, gene-based or tissue-engineered products in animals has uncovered the intricate limitations of in vivo models. There is, therefore, a growing need for innovative non-animal methods to better mimic patient immune responses to ATMPs. The JRC's EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) conducted a study to review the state-of-the art of advanced non-animal models used in immunogenicity testing for ATMPs. The majority of the 88 models that were identified were based on in vitro techniques with a limited amount of in silico methods, and most of these focused on the investigation of cell therapy products. Furthermore, most of the identified methods used classical 2D primary cell cultures in a low throughput format, typically yielding limited amounts of measurement information. This review highlights a pressing need for the development and acceptance of more sophisticated and innovative non-animal approaches in this field which will pave the way for the broader use of ATMPs in the clinic.